Infusion set and inserter assembly

Abstract

To provide a two stage infusion set inserter system.SOLUTION: The inserter system includes a housing including a rotatable button assembly and a non-rotatable portion of the housing comprising a ramp and a tab recess, a slide component comprising a slide component tab, and a needle carrier connected to an introducer needle, the needle carrier comprising: An inserter assembly including a needle carrier, a slide component spring, and a needle spring that are slidably movable from a start position to an injection position and then to a second end position, wherein the rotatable button assembly rotates from a locked position to an unlocked position, wherein when a force is applied on top of the rotatable button assembly, the slide component and the needle carrier are forced downward by the slide component spring, and wherein when the needle carrier reaches the injection position, the needle spring forces the needle carrier upward toward the second end position.SELECTED DRAWING: Figure 60

Description

[Technical Field]

[0001] FIELD OF THE INVENTION This application relates generally to infusion sets and inserter assemblies for infusion sets, and more particularly to infusion sets, inserter assemblies, and methods of using the same. [Background technology]

[0002] Many potentially valuable drugs or compounds, including biological agents, are not orally effective due to poor absorption, hepatic metabolism, or other pharmacokinetic factors. In addition, some therapeutic compounds, although they can be orally absorbed, require occasional administration, and thus often make it difficult for patients to maintain the desired schedule. In these cases, parenteral delivery is often employed or can be employed.

[0003] Effective parenteral routes of drug delivery, as well as other fluids and compounds, such as subcutaneous injection, intramuscular injection, and intravenous (IV) administration, involve penetration of the skin with a needle or stylet. Insulin is an example of a therapeutic fluid that is self-injected by millions of diabetic patients. Users of parenterally delivered drugs could benefit from wearable devices that would automatically deliver the needed drug / compound over a period of time.

[0004] To this end, efforts have been made to design portable and wearable devices for the controlled release of therapeutic agents. Such devices are known to have a reservoir, such as a cartridge, syringe, or bag, and to be electronically controlled. These devices suffer from several drawbacks, including failure rates. Reducing the size, weight, and cost of these devices is also a continuing challenge. In addition, these devices are often applied to the skin, presenting the challenge of frequent re-application. Summary of the Invention [Means for solving the problem]

[0005] According to one implementation, a two-stage infusion set inserter system is disclosed. The inserter system includes a housing including a rotatable button assembly and a non-rotatable portion of the housing including a ramp and tab recess, a slide component including a slide component tab, a needle carrier connected to an introducer needle, the needle carrier being slidably movable from a start position to an injection position and then to a second, end position, the inserter assembly including the needle carrier, a slide component spring, and a needle spring, wherein the rotatable button assembly rotates from a locked position to an unlocked position, and when a force is applied on the rotatable button assembly, the slide component and needle carrier are urged downward by the slide component spring, and when the needle carrier reaches the injection position, the needle spring urges the needle carrier upward toward the second, end position.

[0006] Some embodiments of this implementation may include one or more of the following: The rotatable button assembly includes a ramp and a tab recess. The slide component includes a slide component tab. When the rotatable button assembly is in the locked position, the slide component tab is in the tab recess. When the rotatable button assembly is in the unlocked position, the ramp contacts the slide component tab. The system further includes an infusion set attached to the housing. The infusion set includes a base, the base including an adhesive layer. The adhesive layer includes an adhesive liner. The system further includes a slider stop, where when the slide component reaches the slider stop, the slider stop stops the slide component from moving downward. The needle carrier includes a spring finger, where when the needle carrier interacts with the slide stop, the slide stop urges the spring finger inward, moving the needle carrier from the injection position to the end position. The system further includes an introducer needle connected to the needle carrier, wherein when the needle carrier moves to the end position, the introducer needle moves to the end position and the introducer needle is inside the housing portion, the rotatable button assembly includes a first alignment mark and the non-rotatable portion of the housing includes a second alignment mark, wherein when the rotatable button assembly is rotated from the locked position to the unlocked position, the first alignment mark and the second alignment mark align to indicate the system is in the unlocked position.

[0007] According to another implementation, an injection device is disclosed that includes a base portion including a cannula and a septum retainer with a retainer cutout, the cannula positioned within the retainer cutout, and a connector with a connector needle removably attached to the base portion, the cannula being pivotable within the retainer cutout relative to the base.

[0008] Some embodiments of this implementation may include one or more of the following. The base portion further includes a cutout area configured to receive a length of tubing. The connector includes connector fingers including a rib-like pattern. The connector includes a connector needle protector positioned over the connector needle. The retainer cutout includes a topically applied ointment. The device further includes a length of tubing connector to the connector. The base further includes a finger grip area configured for finger grip stability during connection of the base and the connector. The retainer cutout is conical.

[0009] The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the description, drawings, and claims. The present specification also provides, for example, the following items: (Item 1) 1. A two-stage infusion set inserter system, the system comprising an inserter assembly, the inserter assembly comprising: A housing, the housing comprising: a rotatable button assembly including a ramp and a tab recess; The non-rotatable part of the housing and a housing comprising: a slide component having a slide component tab; a needle carrier connected to the introducer needle, said needle carrier being slidably movable from a start position to an injection position and then to a second, end position; a slide component spring; Needle springs and Equipped with the rotatable button assembly rotates from a locked position to an unlocked position; when a force is applied on the rotatable button assembly, the slide component and needle carrier are urged downward by the slide component spring; When the needle carrier reaches the injection position, the needle spring urges the needle carrier upward toward the second end position. (Item 2) Item 10. The system of item 1, wherein the rotatable button assembly includes a ramp and a tab recess. (Item 3) Item 3. The system of item 2, wherein the slide component comprises a slide component tab. (Item 4) 4. The system of claim 3, wherein the slide component tab is within the tab recess when the rotatable button assembly is in the locked position. (Item 5) Item 5. The system of item 4, wherein when the rotatable button assembly is in the unlocked position, the ramp contacts the slide component tab. (Item 6) Item 10. The system of item 1, further comprising an infusion set attached to the housing. (Item 7) 7. The system of claim 6, wherein the infusion set comprises a base, the base comprising an adhesive layer. (Item 8) Item 8. The system of item 7, wherein the adhesive layer comprises an adhesive liner. (Item 9) Item 10. The system of item 1, further comprising a slider stop, the slider stop causing the sliding component to stop downward movement when the sliding component reaches the slider stop. (Item 10) 8. The system of claim 7, wherein the needle carrier comprises spring fingers, and when the needle carrier interacts with a slide stop, the slide stop urges the spring fingers inward, moving the needle carrier from the injection position to the end position. (Item 11) Item 9. The system of item 8, further comprising an introducer needle connected to the needle carrier, wherein when the needle carrier moves to the end position, the introducer needle moves to the end position, and the introducer needle is inside the housing portion. (Item 12) 2. The system of claim 1, wherein the rotatable button assembly includes a first alignment mark and the non-rotatable portion of the housing includes a second alignment mark, and when the rotatable button assembly is rotated from a locked position to an unlocked position, the first alignment mark and the second alignment mark align, indicating that the system is in the unlocked position. (Item 13) 1. An injection device, comprising: a base portion, the base portion comprising: A cannula and a bulkhead retainer having a retainer cutout; a base portion, the cannula positioned within the retainer cutout; a connector having a connector needle; Equipped with An infusion device wherein the connector is removably attached to the base portion and the cannula is pivotable within the retainer cutout relative to the base. (Item 14) Item 14. The infusion device of item 13, wherein the base portion further comprises a cutout area configured to receive a length of tubing. (Item 15) Item 14. The infusion device of item 13, wherein the connector comprises connector fingers comprising a rib-like pattern. (Item 16) Item 14. The injection device of item 13, wherein the connector includes a connector needle protector positioned over the connector needle. (Item 17) Item 14. The injection device of item 13, wherein the retainer cutout comprises a topically administered ointment. (Item 18) Item 14. The infusion device of item 13, further comprising a length of tubing connector to the connector. (Item 19) Item 14. The injection device of item 13, wherein the base further comprises a finger grip area, the finger grip area configured for finger grip stability during connection of the base and the connector. (Item 20) Item 14. The injection device of item 13, wherein the retainer cutout is conical. [Brief explanation of the drawings]

[0010] [Figure 1] 1-5 show various views of one embodiment of an infusion set. [Figure 2] 1-5 show various views of one embodiment of an infusion set. [Figure 3] 1-5 show various views of one embodiment of an infusion set. [Figure 4] 1-5 show various views of one embodiment of an infusion set. [Figure 5] 1-5 show various views of one embodiment of an infusion set. [Figure 6] 6-13 show various views of one embodiment of an infusion set. [Figure 7]6-13 show various views of one embodiment of an infusion set. [Figure 8] 6-13 show various views of one embodiment of an infusion set. [Figure 9] 6-13 show various views of one embodiment of an infusion set. [Figure 10] 6-13 show various views of one embodiment of an infusion set. [Figure 11] 6-13 show various views of one embodiment of an infusion set. [Figure 12] 6-13 show various views of one embodiment of an infusion set. [Figure 13] 6-13 show various views of one embodiment of an infusion set. [Figure 14] FIG. 14 is a diagram of one embodiment of a connector for an infusion set. [Figure 15] 15-18 show various views of one embodiment of an infusion set. [Figure 16] 15-18 show various views of one embodiment of an infusion set. [Figure 17] 15-18 show various views of one embodiment of an infusion set. [Figure 18] 15-18 show various views of one embodiment of an infusion set. [Figure 19] 19-22 show various views of one embodiment of an infusion set. [Figure 20] 19-22 show various views of one embodiment of an infusion set. [Figure 21] 19-22 show various views of one embodiment of an infusion set. [Figure 22] 19-22 show various views of one embodiment of an infusion set. [Figure 23] 23-33 show various views of one embodiment of an infusion set inserter system. [Figure 24] 23-33 show various views of one embodiment of an infusion set inserter system. [Figure 25]23-33 show various views of one embodiment of an infusion set inserter system. [Figure 26] 23-33 show various views of one embodiment of an infusion set inserter system. [Figure 27] 23-33 show various views of one embodiment of an infusion set inserter system. [Figure 28] 23-33 show various views of one embodiment of an infusion set inserter system. [Figure 29] 23-33 show various views of one embodiment of an infusion set inserter system. [Figure 30] 23-33 show various views of one embodiment of an infusion set inserter system. [Figure 31] 23-33 show various views of one embodiment of an infusion set inserter system. [Figure 32] 23-33 show various views of one embodiment of an infusion set inserter system. [Figure 33] 23-33 show various views of one embodiment of an infusion set inserter system. [Figure 34] 34-43 show various views of one embodiment of an infusion set inserter system. [Figure 35] 34-43 show various views of one embodiment of an infusion set inserter system. [Figure 36] 34-43 show various views of one embodiment of an infusion set inserter system. [Figure 37] 34-43 show various views of one embodiment of an infusion set inserter system. [Figure 38] 34-43 show various views of one embodiment of an infusion set inserter system. [Figure 39] 34-43 show various views of one embodiment of an infusion set inserter system. [Figure 40] 34-43 show various views of one embodiment of an infusion set inserter system. [Figure 41]34-43 show various views of one embodiment of an infusion set inserter system. [Figure 42] 34-43 show various views of one embodiment of an infusion set inserter system. [Figure 43] 34-43 show various views of one embodiment of an infusion set inserter system. [Figure 44] 44-48 show various views of one embodiment of an infusion set inserter system. [Figure 45] 44-48 show various views of one embodiment of an infusion set inserter system. [Figure 46] 44-48 show various views of one embodiment of an infusion set inserter system. [Figure 47] 44-48 show various views of one embodiment of an infusion set inserter system. [Figure 48] 44-48 show various views of one embodiment of an infusion set inserter system. [Figure 49] FIG. 49 is a diagram of one embodiment of an infusion set. [Figure 50] 50A-50C show various views of one embodiment of an infusion set. [Figure 51] 51A-51D show various views of one embodiment of a septum retainer. [Figure 52] 52A-52D show various views of one embodiment of a septum retainer. [Figure 53] 53A-53C show various views of one embodiment of a septum retainer. [Figure 54A] 54A-54B show various views of one embodiment of an infusion set. [Figure 54B] 54A-54B show various views of one embodiment of an infusion set. [Figure 55A] 55A-55C show various views of one embodiment of a base for an infusion set. [Figure 55B] 55A-55C show various views of one embodiment of a base for an infusion set. [Figure 55C]55A-55C show various views of one embodiment of a base for an infusion set. [Figure 56A] 56A-56B show various views of one embodiment of a septum retainer. [Figure 56B] 56A-56B show various views of one embodiment of a septum retainer. [Figure 57A] 57A-57B show various views of one embodiment of a connector for an infusion set. [Figure 57B] 57A-57B show various views of one embodiment of a connector for an infusion set. [Figure 58] FIG. 58 is a diagram of one embodiment of an infusion set. [Figure 59] 59-71 are various views and configurations of the inserter assembly / infusion set inserter system. [Figure 60] 59-71 are various views and configurations of the inserter assembly / infusion set inserter system. [Figure 61] 59-71 are various views and configurations of the inserter assembly / infusion set inserter system. [Figure 62] 59-71 are various views and configurations of the inserter assembly / infusion set inserter system. [Figure 63] 59-71 are various views and configurations of the inserter assembly / infusion set inserter system. [Figure 64] 59-71 are various views and configurations of the inserter assembly / infusion set inserter system. [Figure 65] 59-71 are various views and configurations of the inserter assembly / infusion set inserter system. [Figure 66] 59-71 are various views and configurations of the inserter assembly / infusion set inserter system. [Figure 67] 59-71 are various views and configurations of the inserter assembly / infusion set inserter system. [Figure 68]59-71 are various views and configurations of the inserter assembly / infusion set inserter system. [Figure 69] 59-71 are various views and configurations of the inserter assembly / infusion set inserter system. [Figure 70] 59-71 are various views and configurations of the inserter assembly / infusion set inserter system. [Figure 71] 59-71 are various views and configurations of the inserter assembly / infusion set inserter system. DETAILED DESCRIPTION OF THE INVENTION

[0011] Like reference symbols in the various drawings indicate like elements.

[0012] In various embodiments, an infusion set may be used with the infusion device and system and method, and may be used with the inserter assembly. In various embodiments, the infusion set is configured to be inserted into the subcutaneous layer of a user's skin and fluidly connected to a fluid source. In various embodiments, the infusion set may be fluidly connected to a length of tubing and / or an infusion pump. The infusion pump includes any infusion pump, including, but not limited to, U.S. Patent Application No. 13 / 788,260, filed March 7, 2013, entitled "Infusion Pump Assembly" (now U.S. Patent Publication No. US-2014-0107579, Attorney Docket No. K40, published April 17, 2014); U.S. Patent No. 8,491,570, issued July 23, 2013, entitled "Infusion Pump Assembly" (Attorney Docket No. G75); U.S. Patent No. 8,414,522, issued April 9, 2013, entitled "Fluid Delivery Systems and Methods" (Attorney Docket No. E70); U.S. Patent No. 8,414,522, issued September 11, 2012, entitled "Infusion Pump Assembly" (Attorney Docket No. E70); No. 8,262,616 (Attorney Docket No. F51), entitled "Loading Mechanism for Infusion Pump," and U.S. Patent No. 7,306,578 (Attorney Docket No. C54), issued December 11, 2007, entitled "Loading Mechanism for Infusion Pump," all of which are attached hereto and incorporated by reference in their entireties. In various embodiments, the various embodiments of the infusion devices described herein may be used alone or in conjunction with an infusion set.

[0013] Various embodiments are described and illustrated herein. Each embodiment of each element may be used with any other embodiment of any device. Each embodiment of the inserter device may be used with any embodiment of the infusion set device.

[0014] A system is disclosed that includes an infusion set and an inserter device. In various embodiments, the inserter device includes one or more disposable portions.

[0015] (infusion set) In various embodiments, an infusion set is disclosed. Referring now to Figures 1-5, an embodiment of an infusion set 10 is shown. In various embodiments, the infusion set 10 includes a connector 12, tubing 14, a connector needle 16, a septum 18, a septum retainer 20, a base 22, a cannula 24, and an introducer needle 26. The connector 12 includes the connector needle 16, which, when brought into contact with the base 22, is inserted through the septum 18, thereby establishing fluid communication with the cannula 24. Additionally, in some embodiments, one of which is shown in Figure 5, the infusion set may additionally include a funnel 28, which, in various embodiments, may be desirable / beneficial for functioning as a needle guide and for guiding the introducer needle 26.

[0016] 1-6 and 49, in various embodiments, the septum 18 is an interference fit within the base 22, and the septum retainer 20, introducer needle 26, and funnel 28 are also interference fit within the base 22. In various embodiments, the base 22 includes a cutout area 30. The cutout area 30 is configured to accommodate a length of tubing 14 when it is wrapped around the infusion set 10. This may be beneficial / desirable for a number of reasons, including, but not limited to, preventing kinking of the tubing 14, because when the tubing 14 is wrapped around the infusion set 10 and pulled in various directions or angles, the tubing may have less chance of kinking and kinking may cause blockages. In various embodiments, the cutout area 30 functions as a tubing containment.

[0017] In various embodiments, the tubing 14 may be wrapped around the infusion set 10 and clipped or otherwise secured in place. The clipping or securing may occur in any orientation. Thus, in various embodiments, wrapping the tubing around the infusion set 10 may allow the direction of the tubing to change. In some embodiments, the tubing 14 may be routed underneath the infusion set 10 and change direction.

[0018] In various embodiments, the base 22 includes an adhesive layer on the bottom. However, in various other embodiments, the base may not include an adhesive layer on the bottom. In some embodiments, the adhesive layer may be covered with paper or other covering to prevent exposure of the adhesive prior to adhesion to the user / patient's skin. Prior to adhesion to the skin, the paper or other covering may be removed and the base 22 may be pressed against the user / patient's skin. The adhesive maintains the base 22 on the skin.

[0019] In some embodiments, an adhesive layer may be included on an inserter device, such as one of the various embodiments described herein. In some of these embodiments, when the infusion set is pushed toward the user, the infusion set comes into contact with the adhesive layer. However, in some embodiments, the adhesive layer may be located on both the inserter and the infusion set.

[0020] Referring now to FIG. 1 , in various embodiments of the infusion set 10, the base 22 may include a retainer cutout 32. In various embodiments, the retainer cutout 32 may be conical in shape and may provide sufficient room for the cannula 24 to move relative to the base 22 as the base 22 moves due to its location on the user / patient's skin. In various embodiments, the retainer cutout 32 may be any shape or size, including the shape and size shown in FIG. 1 . In various embodiments, the retainer cutout 32 may be beneficial / desirable for a number of reasons, including, but not limited to, providing sufficient room so that the cannula 24 does not shear if the user's skin moves while the infusion set 10 is attached to the user. Thus, the retainer cutout 32 essentially moves the pivot point of the cannula 24 further away from the skin than if the retainer cutout 32 were not included.

[0021] Still referring to FIGS. 1-6, in various embodiments, the cannula 24 may be tapered, and in some embodiments, the cannula 24 may not be tapered.

[0022] 6-13, an embodiment of the base 22 and connector 12 is shown. The base includes an adhesive layer 46, and as previously described, the base may also include a liner / paper or other material to protect the adhesive layer 46. The base 22 includes connector receivers 34, 36 configured to receive connector fingers 38, 40. The connector fingers 38, 40 slide into the connector receivers 34, 36 and snap or lock into place, such that once snapped or locked into place, the connector 12 and base 22 are mated or mated and will not unmated or unmated until or unless the connector release portions 42, 44 are pressed toward each other. Pressing the connector release portions 42, 44 toward each other releases the connector fingers 38, 40 so that they can be removed from the connector receivers 34, 36.

[0023] Connector 12 is removably attached to base 22 by sliding connector fingers 38, 40 of connector 12 into connector receivers 34, 36 on base 22. This action also causes connector needle 16 to pierce septum 18 of base 22 so that connector needle 16 is fluidly connected to cannula 24. Once connector needle 16 is fluidly connected to cannula 24, fluid flowing through tubing 14 (which, in various embodiments, may be fluidly connected to a reservoir within an infusion pump), for example, from an infusion pump or other fluid source, can flow through cannula 24 and into the user / patient.

[0024] 14, in some embodiments, rather than the base including the cutout area, the connector 48 may include the cutout area 50. However, in various embodiments, both the base and the connector may include a cutout area, and in some embodiments, either the base or the connector may or may not include a cutout area.

[0025] 15-18, another embodiment of an infusion set 52 is shown. In this embodiment, the connector 54 includes a curved connector needle 58 and tubing 56 that is in fluid communication with a cannula 66 when the connector 54 is mated or attached to a base 64. This embodiment of the infusion set 52 also includes a funnel 68 that serves as a retainer cutout and functions similarly to that described above. In this embodiment, the connector 54 mates with the base 64 by being lowered onto the top of the base 64. The curved connector needle 58 is configured so that the connector needle 58 can spin 360 degrees. The connector needle 58 is centered on the septum 60 when connected to the base. In various embodiments, the curved connector needle 58 is aligned with the base 64 such that it is centered when the curved connector needle 58 is attached to the base 64 to maintain a seal, thereby maintaining a leak-proof seal upon rotation.

[0026] 19-22, another embodiment of the infusion set 70 is shown. In some embodiments of the infusion set 70, the introducer needle 86 may be "c" shaped (or "v" shaped or half-moon shaped, etc.) and may encase the cannula 84, such that the cannula 84 is inside the introducer needle 86. In this embodiment, the introducer needle 86 is "c" shaped, but in other embodiments, the introducer needle 86 may be any shape, including, but not limited to, encasing most, or essentially, or nearly completely, the cannula 84 (in some embodiments, the needle may completely encase the cannula 84, while in other embodiments, the needle may encase the cannula less than completely). A "c" shaped introducer needle 86 may be desirable / beneficial for a number of reasons, including, but not limited to, allowing the introducer needle 86 to freely slide away from the cannula 84 after insertion of the cannula 84 into the user / patient without having to pull or otherwise remove the cannula 84 from inside the user / patient (which may be at risk if the introducer needle is inside the cannula). Additionally, in embodiments where the introducer needle is "c" shaped or otherwise surrounds the cannula 84, the introducer needle 86 protects the cannula. As shown in the figures, the introducer needle 86 extends past the cannula 84 and thus pushes through the skin; however, in various embodiments, the introducer needle 86 has an angled tip 88, which assists in the introducer needle 86 clearing the cannula 84 (i.e., assists in moving the cannula 84 out of the way so that the introducer needle 86 is released) once insertion of the cannula 84 is complete.

[0027] Additionally, the "c" shaped introducer needle 86 around the cannula 84 allows the cannula 84 to be smaller in diameter than, for example, an infusion set whose introducer needle is inside the cannula. A smaller diameter cannula may be desirable / beneficial for many reasons, including, but not limited to, the cannula being able to be bent 90 degrees without breaking or kinking, which may therefore be more flexible, leading to a more comfortable experience for the user / patient, and / or the cannula being less susceptible to blockage.

[0028] Infusion set 70 also includes a connector 72, which includes tubing 74. Connector 72 connects to a base 82.

[0029] The various embodiments of the infusion sets described above exhibit many advantages and may therefore be beneficial / desirable for many reasons, including, but not limited to, the following: In various embodiments, the infusion set design prevents or reduces the chance of tubing kinking. Additionally, the infusion set design allows for tubing to extend at any angle from the cannula site, which in various embodiments may allow for shorter tubing, more comfort and various positioning, and no alignment with the infusion set may be required. Thus, a user may insert the infusion set at any angle or direction and still have the desired tubing orientation / position.

[0030] In various embodiments, a retainer cutout is included, as described above. In some of these embodiments of the infusion set, an antiseptic or other locally applied ointment, whether medicinal or nutrient or otherwise, may be included. Thus, upon attachment of the infusion set to the user and insertion of the cannula, an antiseptic or other locally applied ointment, whether medicinal or nutrient or otherwise, may be introduced onto the user's skin. This may be beneficial / desirable for a number of reasons, including, but not limited to, preventing infection and / or introducing medicinal or nutrient or nutritional compounds to the user in a convenient manner.

[0031] 50A-50C, another embodiment of an infusion set 200 is shown. In various embodiments, the infusion set 200 includes a connector 202, tubing 204, a connector needle 206, a septum 208, a septum retainer 210, a base 212, a cannula 218, and an introducer needle 214. The connector 202 includes the connector needle 206 that is inserted through the septum 208 so as to be in fluid communication with the cannula 218 when the connector 202 is brought into contact with the base 212. Additionally, in some embodiments, the infusion set may include a funnel (not shown, see FIG. 5), which in various embodiments may be desirable / beneficial as it acts as a needle guide and guides the introducer needle 214.

[0032] Still referring to FIGS. 50A-50C, in various embodiments, the septum 208 is an interference fit within the base 212, and the septum retainer 210 and introducer needle 214 are also an interference fit within the base 212.

[0033] In various embodiments, base 212 includes adhesive layer 220 on the bottom. However, in various other embodiments, base 212 may not include adhesive layer 220 on the bottom. In some embodiments, adhesive layer 220 may be covered with paper or other covering to prevent exposure of the adhesive prior to adhesion to the user / patient's skin. Prior to adhesion to the skin, the paper or other covering may be removed and base 212 may be pressed against the user / patient's skin. The adhesive maintains base 212 on the skin.

[0034] In some embodiments, the adhesive layer 220 may be included on an inserter device, such as one of the various embodiments described herein. In some of these embodiments, when the infusion set is pushed toward the user, the infusion set comes into contact with the adhesive layer. However, in some embodiments, the adhesive layer may be located on both the inserter and the infusion set.

[0035] 51A-51D, in some embodiments, septum retainer 210 can be molded as shown in FIG. 50C. Septum retainer 210 is shown in more detail in FIGS. 51A-51D. In various embodiments, septum retainer 210 is an interference fit within base 212 of infusion set 200. In various embodiments, septum retainer 210 is retained within base 212 by septum retainer fingers 224, 226. However, in various other embodiments, other mechanisms for retention can be used. In some embodiments, septum retainer 210 can be ultrasonically or otherwise welded into base 212.

[0036] In various embodiments, cannula 218 may be manufactured from the same material as septum retainer 210, and in some embodiments, cannula 218 and septum retainer 210 may be ultrasonically welded, heat bonded, or otherwise attached together.

[0037] In various embodiments of the infusion set 200, the base 212 may include a septum retainer 210, which may include a retainer cutout 216. In various embodiments, the retainer cutout 216 may be conical in shape and may provide sufficient room for the cannula 218 to move relative to the base 212 as the base 212 moves due to its location on the user's / patient's skin. In various embodiments, the retainer cutout 216 may be any shape or size, including the shape and size shown in FIG. 51B. In various embodiments, the retainer cutout 216 may be beneficial / desirable for a number of reasons, including, but not limited to, providing sufficient room so that the retainer cutout 216 does not shear the cannula 218 if the user's skin moves while the infusion set 200 is attached to the user. Thus, retainer cutout 216 essentially moves the pivot point of cannula 218 further away from the skin than would be the case if retainer cutout 216 were not included.

[0038] In various embodiments, the cannula 218 may be tapered, and in some embodiments, the cannula 218 may not be tapered.

[0039] In various embodiments, an antiseptic or other locally delivered ointment, whether medicinal or nutritional, or otherwise, may be contained within the retainer cutout 216. Thus, upon attachment of the infusion set 200 to the user and insertion of the cannula 218, an antiseptic or other locally delivered ointment, whether medicinal or nutritional, or otherwise, may be introduced onto the user's skin. This may be beneficial / desirable for a number of reasons, including, but not limited to, preventing infection and / or introducing medicinal or nutritional agents or compounds to the user in a convenient manner.

[0040] 52A-52D, in some embodiments, septum retainer 228 may be molded as shown. In various embodiments, septum retainer 228 is an interference fit within base 212 of infusion set 200. In various embodiments, septum retainer 228 is retained within base 212 by septum retainer fingers 236, 238. However, in various other embodiments, other mechanisms for retention may be used. In some embodiments, septum retainer 228 may be ultrasonically or otherwise welded into base 212.

[0041] In various embodiments, cannula 234 may be manufactured from the same material as septum retainer 228, and in some embodiments, cannula 234 and septum retainer 228 may be molded as a single piece.

[0042] In various embodiments of the infusion set 200, the base 212 may include a septum retainer 228, which may include a retainer cutout 230. In various embodiments, the retainer cutout 230 may be round and / or conical in shape and may provide sufficient room for the cannula 234 to move relative to the base 212 as the base 212 moves due to its location on the user's / patient's skin. In various embodiments, the retainer cutout 230 may be any shape or size, including the shapes and sizes shown in FIGS. 52B and 52D. In various embodiments, the retainer cutout 230 may be beneficial / desirable for a number of reasons, including, but not limited to, providing sufficient room so that the retainer cutout 230 does not shear the cannula 234 if the user's skin moves while the infusion set 200 is attached to the user. Thus, retainer cutout 230 essentially moves the pivot point of cannula 234 further away from the skin than would be the case if retainer cutout 230 were not included.

[0043] In various embodiments, the cannula 234 may be tapered, and in some embodiments, the cannula 234 may not be tapered.

[0044] In various embodiments, an antiseptic or other locally delivered ointment, whether medicinal or nutritional, or otherwise, may be contained within the retainer cutout 230. Thus, upon attachment of the infusion set 200 to the user and insertion of the cannula 234, an antiseptic or other locally delivered ointment, whether medicinal or nutritional, or otherwise, may be introduced onto the user's skin. This may be beneficial / desirable for a number of reasons, including, but not limited to, preventing infection and / or introducing medicinal or nutritional agents or compounds to the user in a convenient manner.

[0045] In various embodiments, septum retainer 228 can include a needle guide 240 that guides introducer needle 214 through septum 208 and into cannula 234. In various embodiments, needle guide 240 can be any shape or size, including but not limited to the shape and size shown in FIG.

[0046] 53A-53C, in some embodiments, septum retainer 242 may be molded as shown. In various embodiments, septum retainer 242 is an interference fit within base 212 of infusion set 200. In various embodiments, septum retainer 242 is retained within base 212 by septum retainer fingers 250, 252. However, in various other embodiments, other mechanisms for retention may be used. In some embodiments, septum retainer 242 may be ultrasonically or otherwise welded into base 212.

[0047] In various embodiments, cannula 248 can be manufactured from the same material as septum retainer 242, and in some embodiments, cannula 248 and septum retainer 242 can be molded as a single piece. In some embodiments, cannula 248 can be funnel-shaped, as shown in FIG. 53C. In various embodiments, cannula 248 can be attached to septum retainer 242.

[0048] In various embodiments of the infusion set 200, the base 212 may include a septum retainer 242, which may include a retainer cutout 244. In various embodiments, the retainer cutout 244 may be round and / or conical in shape and may provide sufficient room for the cannula 248 to move relative to the base 212 as the base 212 moves due to its location on the user's / patient's skin. In various embodiments, the retainer cutout 244 may be any shape or size, including the shape and size shown in FIG. 53B. In various embodiments, the retainer cutout 244 may be beneficial / desirable for a number of reasons, including, but not limited to, providing sufficient room so that the retainer cutout 244 does not shear the cannula 248 if the user's skin moves while the infusion set 200 is attached to the user. Thus, the retainer cutout 244 essentially moves the pivot point of the cannula 248 further away from the skin than would be the case if the retainer cutout 244 were not included.

[0049] In various embodiments, the cannula 248 may be tapered, and in some embodiments, the cannula 248 may not be tapered.

[0050] In various embodiments, an antiseptic or other locally delivered ointment, whether medicinal or nutritional, or otherwise, may be contained within the retainer cutout 244. Thus, upon attachment of the infusion set 200 to the user and insertion of the cannula 248, an antiseptic or other locally delivered ointment, whether medicinal or nutritional, or otherwise, may be introduced onto the user's skin. This may be beneficial / desirable for a number of reasons, including, but not limited to, preventing infection and / or introducing medicinal or nutritional agents or compounds to the user in a convenient manner.

[0051] In various embodiments, septum retainer 242 may include a needle guide 246 that guides introducer needle 214 through septum 208 and into cannula 248. In various embodiments, needle guide 246 may be any shape or size, including, but not limited to, the shape and size shown in FIG. 53B . In various embodiments, needle guide 246 may be made from a different material than septum retainer 242. For example, in some embodiments, needle guide 246 may be made from metal. In some embodiments, cannula 248 may be an interference fit within septum retainer 242, and then metal needle guide 246 may be an interference fit within septum retainer 242. In various embodiments, this manufacturing method provides an interference fit.

[0052] 54A-58B, another embodiment of an infusion set 300 is shown. In various embodiments, the infusion set 300 includes a connector 302, tubing 304 / length of tubing 304, a connector needle 306, a septum 308, a septum retainer 310, a base 312, a cannula 314, and an introducer needle 306. The connector 302 includes the connector needle 306 that is inserted through the septum 308 so as to be in fluid communication with the cannula 314 when contacted with the base 312. Additionally, in some embodiments, the infusion set may additionally include a funnel 28, one of which is shown in FIG. 5, which in various embodiments may be desirable / beneficial as it acts as a needle guide and guides the introducer needle 26.

[0053] 54A-54B, and also with reference to FIGS. 55A-55C and 56A-56B, in various embodiments, the septum 308 is an interference fit within the base 312, and the septum retainer 310, introducer needle 26 (not shown, see e.g., FIG. 5), and funnel 28 (not shown, see e.g., FIG. 5) are also interference fit within the base 312. In various embodiments, the base 312 includes a cutout area 320. The cutout area 320 is configured to accommodate the length of tubing 304 when it is wrapped around the infusion set 300. This can be beneficial / desirable for a number of reasons, including, but not limited to, preventing kinking of the tubing 304, as the tubing 304, when wrapped around the infusion set 300, may have less chance of kinking and kinking can cause blockages when pulled in various directions or angles. In various embodiments, the cutout area 320 serves as a tubing storage.

[0054] In various embodiments, the tubing 304 may be wrapped around the infusion set 300 and clipped or otherwise secured in place. The clipping or securing may occur in any orientation. Thus, in various embodiments, wrapping the tubing around the infusion set 300 may allow the direction of the tubing 304 to change. In some embodiments, the tubing 304 may be routed underneath the infusion set 300 and change direction.

[0055] In various embodiments, the base 312 includes a finger grip area 408, which in some embodiments is a concave area within the base 312 configured for finger grip stability while connecting or disconnecting the base 312 to or from the connector 302. In various embodiments, the rear edge of the base 312 is curved inward and a portion of the base is curved outward to form a concave slot or area that can be used as a finger grip or finger hold. This can be beneficial / desirable for a number of reasons, including, but not limited to, allowing a more stable finger force to be exerted on the base, which can be beneficial / desirable during connecting and disconnecting to or from the connector 302.

[0056] In various embodiments, the base 312 includes an adhesive layer on the bottom. However, in various other embodiments, the base 312 may not include an adhesive layer on the bottom. In some embodiments, the adhesive layer may be covered with paper or other covering to prevent exposure of the adhesive prior to adhesion to the user / patient's skin. Prior to adhesion to the skin, the paper or other covering may be removed and the base 312 may be pressed against the user / patient's skin. The adhesive maintains the base 312 on the skin.

[0057] In some embodiments, an adhesive layer may be included on an inserter device, such as one of the various embodiments described herein. In some of these embodiments, when the infusion set is pushed toward a user, the infusion set comes into contact with the adhesive layer. However, in some embodiments, the adhesive layer may be located on both the inserter and the infusion set, or only on the inserter or only on the inserter device.

[0058] 1 , in various embodiments of the infusion set 300, for example, as shown in FIGS. 54A-54B , the base 312 may include a retainer cutout 32. In various embodiments, the retainer cutout 32 may be conical in shape and may provide sufficient room for the cannula 314 to move relative to the base 312 as the base 312 moves due to its location on the user / patient's skin. In various embodiments, the retainer cutout 32 may be any shape or size, including the shape and size shown in FIG. 1 . In various embodiments, the retainer cutout 32 may be beneficial / desirable for a number of reasons, including, but not limited to, providing sufficient room so that the retainer cutout 32 does not shear the cannula 314 if the user's skin moves while the infusion set 300 is attached to the user. Thus, the retainer cutout 32 essentially moves the pivot point of the cannula 24 further away from the skin than it would be if the retainer cutout 32 were not included.

[0059] 54A-58B, in various embodiments, cannula 314 can be tapered, and in some embodiments, cannula 24 may not be tapered. An embodiment of a base 312 and connector 302 is shown. Base 312, in some embodiments, includes an adhesive layer (not shown, shown as 46 in FIG. 8), which may also include a liner / paper or the like to protect adhesive layer 46, as described above. Base 312 includes connector receivers 322, 324 configured to receive connector fingers 326, 328. Connector fingers 326, 328 slide into connector receivers 322, 324 and snap or lock into place, such that, once snapped or locked into place, connector 302 and base 312 are mated or mated and will not unmate or unmate until or unless connector release portions 330, 332 are pressed toward one another. Pressing the connector release portions 330, 332 toward each other releases the connector fingers 326, 328 so that they can be removed from the connector receivers 322, 324.

[0060] 58 , connector 302 is removably attached to base 312 by sliding connector fingers 326, 328 of connector 302 into connector receivers 322, 324 on base 312. This action also causes connector needle 306 to pierce septum 308 of base 312 so that connector needle 306 is fluidly connected to cannula 314. Once connector needle 306 is fluidly connected to cannula 314, fluid flowing through tubing 304 (which, in various embodiments, may be fluidly connected to a reservoir within the infusion pump), for example, from an infusion pump or other fluid source, can flow through cannula 314 and into the user / patient.

[0061] 54A-54B and 57A-57B, in various embodiments, connector 302 can include a connector needle protector 340. The embodiment of connector 302 shown in FIGS. 57A-57B does not include a connector needle; however, an embodiment of connector 302 with a connector needle 306 is shown in FIGS. 54A-54B. In various embodiments, the embodiment of connector 302 shown in FIGS. 57A-57B can include a connector needle, for example, as shown in FIGS. 54A-54B.

[0062] Connector needle protector 340, in various embodiments, is made from the same material as connector 302, although in some embodiments, it may be made from a different material than connector 302. In various embodiments, connector needle protector 340 is shaped and sized as shown; however, connector needle protector 340, in various embodiments, may be any size or shape desired. Connector needle protector 340 may be beneficial / desirable for a number of reasons, including, but not limited to, that connector needle protector 340 may prevent or reduce the risk of an unwanted needlestick by a user or user caregiver and / or may prevent a connector needle stick that leads to the risk of contamination of the connector needle and, therefore, of the user and / or fluid delivered through the connector needle.

[0063] In various embodiments, connector 302 includes a rib-like pattern or grip-related features on one or more areas of connector 302. In various embodiments, connector 302 includes a rib-like pattern or grip-related features on connector release portions 330, 332. In some embodiments, the rib-like pattern may include more or fewer pronounced ribs and / or more or fewer ribs than shown. In various embodiments, the grip-related features may include bumps, textured surfaces, and any other grip-related features. In various embodiments, the rib-like pattern and / or any grip-related features may be convex or concave relative to the connector 302 surface. For example, in the embodiment shown in FIGS. 54A-54B , the rib-like pattern is convex. However, in other embodiments, the rib-like pattern may be concave, and in some embodiments, the grip-related features and / or rib-like pattern may include sections of concave and convex features.

[0064] 56A-56B, in some embodiments, septum retainer 310 may be molded as shown in FIGS. 56A-56B, although in some embodiments, septum retainer 310 may be molded as otherwise disclosed herein. In various embodiments, septum retainer 310 is an interference fit within base 312 of infusion set 300. In various embodiments, septum retainer 310 is retained within base 312 by septum retainer fingers 342, 344. However, in various other embodiments, other mechanisms for retention may be used. In some embodiments, septum retainer 310 may be ultrasonically or otherwise welded into base 312.

[0065] Referring now also to Figures 54A-54B and Figures 56A-56B, in various embodiments, cannula 314 may be manufactured from the same material as septum retainer 310, and in some embodiments, cannula 314 and septum retainer 310 may be ultrasonically welded, heat bonded, or otherwise attached together.

[0066] In various embodiments of the infusion set 300, the base 312 may include a septum retainer 310, which may include a retainer cutout (not shown, shown in FIG. 51B as 216). In various embodiments, the retainer cutout may be conical in shape and may provide sufficient room for the cannula 314 to move relative to the base 312 as the base 312 moves due to its location on the user's / patient's skin. In various embodiments, the retainer cutout may be any shape or size, including the shape and size shown in FIG. 51B. In various embodiments, the retainer cutout may be beneficial / desirable for a number of reasons, including, but not limited to, providing sufficient room so that the retainer cutout does not shear the cannula 314 if the user's skin moves while the infusion set 300 is attached to the user. Thus, the retainer cutout essentially moves the pivot point of the cannula 314 further away from the skin than if the retainer cutout were not included.

[0067] The various embodiments of the infusion sets described above exhibit many advantages and may therefore be beneficial / desirable for a number of reasons, including, but not limited to, the following: In various embodiments, the infusion set design prevents or reduces the chance of tubing kinking. Additionally, the infusion set design allows for tubing to extend at any angle from the cannula site, which in various embodiments may allow for short tubing, allowing for more comfort and various positioning, and may allow for no alignment with the infusion set to be required. Thus, a user may insert the infusion set at any angle or orientation and still have the desired tubing orientation / position.

[0068] In various embodiments, a retainer cutout is included, as described above. In some of these embodiments of the infusion set, an antiseptic or other locally applied ointment, whether medicinal or nutrient or otherwise, may be included. Thus, upon attachment of the infusion set to the user and insertion of the cannula, an antiseptic or other locally applied ointment, whether medicinal or nutrient or otherwise, may be introduced onto the user's skin. This may be beneficial / desirable for a number of reasons, including, but not limited to, preventing infection and / or introducing medicinal or nutrient or nutritional compounds to the user in a convenient manner.

[0069] (inserter assembly) In various embodiments, an inserter assembly can be used to insert one or more embodiments of an infusion set, including those described above / herein, which in various embodiments allows an introducer needle and cannula to be introduced into a user / patient through their skin, such that the cannula is inserted through their skin into their subcutaneous region.

[0070] In various embodiments, the inserter assembly actually creates a vacuum such that the skin is pulled into / towards the inserter assembly and towards the introducer needle / cannula assembly, causing the introducer needle / cannula assembly to pierce the user / patient's skin and the base of the infusion set to press against the user / patient's skin.

[0071] This method of cannula insertion can be beneficial / desirable for a number of reasons, including but not limited to, reducing the amount of pain experienced by the user / patient during insertion of the introducer needle / cannula.

[0072] In various embodiments, the inserter assembly does not produce a vacuum.

[0073] 23-33, one embodiment of the inserter assembly 90 is shown. The inserter assembly includes a reusable inserter assembly portion 92, a disposable inserter assembly portion 94, and an infusion set 104 that includes an infusion set base 96. The reusable inserter assembly portion 92 includes a plunger 98 and a plunger spring 100. In the first position of the reusable inserter assembly portion 92, which can be seen in FIG. 23, the plunger 98 is in a first position. The reusable housing assembly portion 92 and the disposable housing assembly portion 94 are not connected. Referring also now to FIG. 24, to begin insertion of the introducer needle / cannula assembly 102, the plunger 98 is depressed to a second position. Depression of plunger 98 compresses plunger spring 100, and the end of the plunger is locked in place by at least one, but in this embodiment at least four, plunger locking fingers (see 126, 128; the other two are not visible in these views). The depressed plunger 98 is held in place by plunger locking fingers 126, 128. In various embodiments, plunger locking fingers 126, 128 are spring-like fingers made from plastic. However, in other embodiments, various designs can be used to hold the depressed plunger 98 in the second position.

[0074] 25 , the reusable housing assembly portion 92 and the disposable housing assembly portion 94 are attached. In various embodiments, the attachment can be achieved by threading the reusable housing assembly portion 92 onto the disposable housing assembly portion 94. In various embodiments, the connection between the reusable housing assembly portion 92 and the disposable housing assembly portion 94 is a removable connection; however, in other embodiments, the connection between these two portions 92, 94 may not be removable. Furthermore, although the reusable housing assembly portion 92 plunger 98 is described and illustrated as being depressed to the second position before the reusable housing assembly portion 92 and the disposable housing assembly portion 94 are attached, in various embodiments, the reusable housing assembly portion 92 and the disposable housing assembly portion 94 can be attached prior to the plunger 98 being depressed to the second position.

[0075] In various embodiments, mounting the disposable inserter assembly portion 94 onto the reusable inserter assembly portion 92 creates a seal for the vacuum to provide suction force onto the user / patient's skin, as will be discussed in more detail below.

[0076] Referring now also to FIG. 25 , when a user / patient and / or caregiver desires to insert the introducer needle / cannula assembly 102 into the user / patient's skin and begin insertion, the insertion assembly 90 is held against and pressed against the user / patient's skin. This pushes the plunger release assembly 110 toward the plunger 98, which triggers the release of the plunger 98 from the plunger locking fingers 126, 128. As the plunger spring 100 compresses, the release of the plunger 98 also allows the plunger spring 100 to decompress, which propels the plunger 98 from the second position to the first position. The movement of the plunger 98 rapidly moving from the second position to the first position creates a vacuum within the disposable inserter assembly portion 94. The O-ring seal assembly 112 seals the disposable inserter assembly portion 94, creating a strong vacuum that also creates a seal against the user's skin. All seals are vacuum-tight. In various embodiments, an additional seal assembly, including but not limited to an O-ring / seal assembly, may also be present around plunger 98. Seal assembly 112 is an O-ring in some embodiments, but in other embodiments, any seal assembly may be used, including but not limited to one or more O-rings, lip seals, or other sealing mechanisms.

[0077] The vacuum draws the user / patient's skin towards the introducer needle / cannula assembly 102 inside the disposable inserter assembly portion 94, and the introducer needle / cannula assembly 102 pierces the user / patient's skin.

[0078] 23-33, the disposable inserter assembly portion 94 includes a needle carrier 114, a needle carrier spring 116, and spring fingers 118, 120. The needle carrier 114 is connected to the introducer needle 122 portion of the introducer needle / cannula assembly 102. The needle carrier spring 116 is maintained in a compressed state by the spring fingers 118, 120. When the spring fingers 118, 120 are released by the action of pressing the plunger release assembly 110 against the user / patient (i.e., the user's skin moves the infusion set, releasing the spring fingers 118, 120), the needle carrier spring 116 is decompressed, which causes the needle carrier 114 to move toward the plunger 98 and away from the user / patient and the infusion set base 96 to move away from the plunger 98 toward the user / patient. This action results in the removal of the introducer needle 122 from the introducer needle / cannula assembly 102. The cannula 124 remains within the user / patient's skin, and the action of decompressing the needle carrier spring 116 provides a force on the infusion set base 96, which in some embodiments includes an adhesive, thus helping the adhesive adhere to the user / patient's skin.

[0079] Referring now also to FIG. 31, once the infusion set base 96 is adhered to the user / patient, the infusion set base 96 is disassociated from the disposable inserter assembly portion 94 (see also FIG. 32), and the reusable inserter assembly portion 92 can be disengaged from its attachment to the disposable inserter assembly portion 94, for example, by unscrewing the disposable inserter assembly portion 94 from the reusable inserter assembly portion 92.

[0080] The overall design of the inserter assembly 90 may be beneficial / desirable for many reasons, including, but not limited to, the ability to reuse most of the inserter assembly 90 while disposing of only the portion that contacts the user / patient's skin. Additionally, the disposable inserter assembly portion 94 holds the introducer needle 122 inside, which therefore provides for sharps disposal and keeps the introducer needle 122 safely inside the plastic housing, preventing unintentional puncture injuries.

[0081] 34-43, another embodiment of an inserter assembly 130 is shown. The inserter assembly includes a reusable inserter assembly portion 132, a disposable inserter assembly portion 134, and an infusion set 144 that includes an infusion set base 136. The reusable inserter assembly portion 132 includes a plunger 138 and a plunger spring 140. In the first position of the reusable inserter assembly portion 132, which can be seen in FIG. 34, the plunger 138 is in a first position. The reusable housing assembly portion 132 and the disposable housing assembly portion 134 are not connected. Referring also now to FIG. 36, the plunger 138 is depressed to a second position to begin insertion of the introducer needle / cannula assembly 142. Depressing the plunger 138 compresses the plunger spring 140, and the ends of the plunger 138 are locked in place by at least one, but in this embodiment at least two, plunger locking fingers 166, 168. The depressed plunger 138 is held in place by the plunger locking fingers 166, 168. In various embodiments, the plunger locking fingers 166, 168 are spring-like fingers made from plastic. However, in other embodiments, various designs can be used to hold the depressed plunger 138 in the second position.

[0082] 35 , the reusable housing assembly portion 132 and the disposable housing assembly portion 134 are attached. In various embodiments, the attachment can be by threading the reusable housing assembly portion 132 onto the disposable housing assembly portion 134. In various embodiments, the connection between the reusable housing assembly portion 132 and the disposable housing assembly portion 134 is a removable connection; however, in other embodiments, the connection between these two portions 132, 134 may not be removable. Furthermore, although the reusable housing portion assembly 132 is described and illustrated as being attached to the disposable housing assembly 134 prior to the plunger 138 being depressed to the second position, in various embodiments, the embodiment shown in FIGS. 34-43 can be modified to allow the plunger 138 to be depressed to the second position prior to the reusable housing portion assembly 132 being attached to the disposable housing assembly 134.

[0083] In various embodiments, mounting the disposable inserter assembly portion 134 onto the reusable inserter assembly portion 132 creates a seal for the vacuum to apply suction to the user / patient's skin, as discussed in more detail below.

[0084] 35 , when a user / patient and / or caregiver desires to insert the introducer needle / cannula assembly 142 into the user / patient's skin and begin insertion, the insertion assembly 130 is held against and pressed against the user / patient's skin. This pushes the plunger release assembly 150 toward the plunger 138, which triggers the release of the plunger 138 from the plunger locking fingers 166, 168. As the plunger spring 140 compresses, the release of the plunger 138 also allows the plunger spring 140 to decompress, which propels the plunger 138 from the second position to the first position. The movement of the plunger 138 rapidly moving from the second position to the first position creates a vacuum within the disposable inserter assembly portion 134. The O-ring seal assembly 152 seals the disposable inserter assembly portion 134, creating a strong vacuum. The seal assembly 152 is an O-ring in some embodiments, but in other embodiments, any seal assembly may be used, including, but not limited to, one or more O-rings, lip seals, or other sealing mechanisms.

[0085] The vacuum draws the user / patient's skin towards the introducer needle / cannula assembly 142 inside the disposable inserter assembly portion 134, and the introducer needle / cannula assembly 142 pierces the user / patient's skin.

[0086] 34-43, the disposable inserter assembly portion 134 includes a needle carrier 154, a needle carrier spring 156, and spring fingers 158, 160. The needle carrier 154 is connected to the introducer needle 162 portion of the introducer needle / cannula assembly 142. The needle carrier spring 156 is maintained in a compressed state by the spring fingers 158, 160. When the spring fingers 158, 160 are released by the action of pressing the plunger release assembly 150 against the user / patient, the needle carrier spring 156 is decompressed, which moves the needle carrier 154 toward the plunger 138 and away from the user / patient, and moves the infusion set base 136 toward the user / patient and away from the plunger 138. This action causes the removal of the introducer needle 162 from the introducer needle / cannula assembly 142. The cannula 164 remains within the user / patient's skin, and the act of decompressing the needle carrier spring 156 provides a force on the infusion set base 136, which in some embodiments includes an adhesive, thus helping the adhesive to adhere to the user / patient's skin.

[0087] 42-43, once the infusion set base 136 is adhered to the user / patient, the infusion set base 136 is disassociated from the disposable inserter assembly portion 134, and the reusable inserter assembly portion 132 can be disengaged from its attachment to the disposable inserter assembly portion 134, for example, by unscrewing the disposable inserter assembly portion 134 from the reusable inserter assembly portion 132.

[0088] The overall design of the inserter assembly 130 may be beneficial / desirable for many reasons, including, but not limited to, the ability to reuse most of the inserter assembly 130 while disposing of only the portion that contacts the user / patient's skin. Additionally, the disposable inserter assembly portion 134 holds the introducer needle 162 inside, which therefore provides for sharps disposal and keeps the introducer needle 162 safely inside the plastic housing, preventing unintentional puncture injuries.

[0089] 44-48, another embodiment of an inserter assembly 170 is shown. The inserter assembly 170 includes a housing portion 172 that is disposable after use and an infusion set 180 that includes an infusion set base 182. The housing portion 172 includes a plunger portion 192 and a plunger spring 176. In the first position of the housing portion 172, which can be seen in FIG. 44, the plunger portion 192 is in the first position.

[0090] 45, when a user / patient and / or caregiver desires to insert introducer needle / cannula assembly 142 into the user / patient's skin and begin insertion, insertion assembly 130 is held against and pressed against the user / patient's skin. To begin insertion of introducer needle / cannula assembly 178, button assembly 174 is depressed and plunger portion 192 is released and begins movement to the second position.

[0091] Referring now also to FIG. 46 , plunger portion 192 moves toward button assembly 174 and away from the user / patient until plunger portion 192 is stopped by locking fingers 194, 196. This is the second position of plunger portion 192. The movement of plunger portion 192 rapidly moving from the first position to the second position creates a vacuum within housing portion 172. O-ring seal assembly 190 seals the bottom portion of housing portion 172, creating a strong vacuum and a seal on the user's skin. The entire seal is vacuum-tight. In various embodiments, an additional seal assembly, including but not limited to an O-ring / seal assembly, may be present around plunger portion 192. Seal assembly 190 is an O-ring in some embodiments, but in other embodiments, any seal assembly may be used, including but not limited to one or more O-rings, lip seals, or other sealing mechanisms.

[0092] The vacuum draws the user / patient's skin towards introducer needle / cannula assembly 178 inside housing portion 172, which pierces the user / patient's skin.

[0093] 44-48 , the housing portion 172 also includes a needle carrier 188. The needle carrier 188 is connected to the introducer needle 184 portion of the introducer needle / cannula assembly 178 and to the plunger spring 176. When the plunger portion 192 is in the second position, the needle carrier 188 continues to move toward the plunger portion 192, away from the user / patient. The needle carrier 188 continues to move toward the base assembly 174, away from the user / patient, removing the introducer needle 184 from the introducer needle / cannula assembly 178. The cannula 164 remains within the user / patient's skin, and the infusion set base 182 of the infusion set 180 is adhered to the user / patient's skin.

[0094] Once the infusion set base 182 is attached to the user / patient, the infusion set 180 is disassociated from the housing portion 174. The overall design of the inserter assembly 170 may be beneficial / desirable for many reasons, including, but not limited to, the disposable housing portion 172 retaining the introducer needle 184 inside, which therefore provides for sharps disposal, keeps the introducer needle 184 safely inside the plastic housing, and prevents unintentional puncture injuries.

[0095] In various embodiments, the inserter can be a two-stage inserter that includes both automated and / or mechanized cannula insertion and introducer needle removal, with the sequence initiated by a single depression of a single button or activation of a release mechanism. Thus, once the sequence is initiated, the inserter will insert the cannula and remove the introducer needle in successive stages without any further user interaction with the inserter. Additionally, in various embodiments described herein, at the end of the second stage, i.e., removal of the introducer needle from the user's body, the introducer needle is nested inside the inserter device / inserter housing. This provides a self-contained sharps container and eliminates user interaction and / or user exposure to the introducer needle. A single-button or single-release mechanism two-stage inserter can be desirable / beneficial for a number of reasons, including, but not limited to, the improved ease, comfort, and convenience of a user simply depressing a button or releasing a release mechanism and having the cannula inserted without any further interaction, including, but not limited to, manual removal of the introducer needle. This may be beneficial / desirable for a number of reasons, including, but not limited to, eliminating the manual removal of the introducer needle reduces the opportunity for the user to visualize the introducer needle, which may reduce the user's anxiety when inserting the cannula, and may reduce and / or eliminate the opportunity for unintentional introducer needle sticks by either the user or caregiver.

[0096] 60-71 , one embodiment of an inserter assembly 350 is shown. The inserter assembly includes a housing portion 352, which includes a rotatable housing portion 360 (which may also be referred to as a button assembly 360 or a rotatable button assembly 360) and a non-rotatable housing portion 362. The inserter assembly 350, in some embodiments, includes a locking direction indicia 354 on the top of the rotatable housing portion 360. In various embodiments, the locking direction indicia include a locked and / or unlocked symbol and one or more arrows indicating the direction for pivoting the rotatable housing portion 360 to change the locked / unlocked position. In FIG. 59 , the inserter assembly 350 is shown in the locked position. The housing portion 352, in some embodiments, includes alignment features, including a first alignment indicia 356 and a second alignment indicia 358, on the rotatable housing portion 360 and the non-rotatable housing portion 362, respectively. In practice, to change the inserter assembly 350 from a locked position (e.g., as shown in FIG. 59 ) to an unlocked position (e.g., as shown in FIG. 61 ), the rotatable portion 360 of the housing is rotated in the direction indicated by the locking direction indicia 354 relative to the non-rotatable portion 362 of the housing until the first alignment indicia 356 is aligned with the second alignment indicia 358. In some embodiments, the first alignment indicia 356 and the second alignment indicia 358 can be different from those shown in FIGS. 59-60 , for example. In various embodiments, the alignment indicia 356, 368 can be any shape and / or size and / or can be any feature on the housing portion 352, including, but not limited to, markings, indentations / embossments, painted features, written features, and / or raised features. Either alignment mark 356, 358 can be any one or more of these types of features, or any other such feature that indicates to the user / caregiver that the inserter assembly 350 is in a locked or unlocked position.

[0097] Still referring to FIGS. 59-71 , button assembly 360 (which may also be referred to as the rotatable portion of the housing) includes ramps 368, 369. In the locked position, ramps 368, 369 do not interact with any other features of the inserter assembly. Button assembly 360 also includes tab recesses 402, which, in the locked position, receive slide component tabs 370, 372. Thus, in the locked position, slide component tabs 370, 372 are inside tab recesses 402, which prevents a force exerted on button assembly 360 in a downward motion (i.e., toward infusion set 398) from moving button assembly 360, and thus button assembly 360 is in the locked position. Thus, button assembly 360 cannot actuate inserter assembly 350 until and unless button assembly 360 (or the rotatable portion of housing 360) is rotated to the unlocked position. This may be beneficial / desirable for a number of reasons, including but not limited to, preventing false or unintended activation of the inserter assembly.

[0098] When the button assembly 360 / rotatable portion of the housing 360 is rotated relative to the non-rotatable portion of the housing 362, the ramps 368, 369 also rotate and the slide component tabs 370, 372 are removed from the tab recesses 402 where they interact with / touch the ramps 368, 369. The first alignment mark 356 and the second alignment mark 358 are aligned. In this position, the button assembly 360 can be actuated, thus initiating the inserter assembly two-step sequence.

[0099] 62-71, the inserter sequence is illustrated and described. To initiate the inserter assembly 350, the user or caregiver applies force / pressure in a downward direction (i.e., toward the infusion set 398) on the button assembly 360. The slide component tabs 370, 372 maintain the slide component 374 in a starting position. As the button assembly 360 advances downward, the ramps 368, 369 push the slide component tabs 370, 372 out of the way of the slide component 374. The slide component spring 390 is released, and the slide component 374 is pushed downward, i.e., toward the infusion set 398 (see FIGS. 63-65). The slide component 374 moves downward, pushing the needle carrier 376 downward. Needle component 376 is connected to introducer needle 394 , at which point cannula 396 is positioned around introducer needle 394 to form introducer needle / cannula assembly 392 .

[0100] The needle carrier 376 and slide component 374 continue to move downward (see FIGS. 66-67). This pushes the insertion set 398 downward toward the user's skin 406. The slide component 374 continues its downward path until the slide component bottom tab 388 strikes the slider stop 384 (see FIG. 69).

[0101] The needle carrier 376 continues its downward path after the slide component bottom tab 388 hits the slider stop 384. At that point, the needle carrier spring fingers 380, 382 of the needle carrier 376 are forced inward by the slider stop 384, and the needle carrier 376 continues downward, following this path, and the downward force of the needle carrier 376 injects the introducer needle / cannula assembly 392 into the user's skin 406 (see FIG. 68).

[0102] When the needle carrier 376 reaches the end of its travel path, the infusion set 398 is on the user's skin and the cannula 396 is inserted into the user. The needle carrier 376 is then released, and the needle spring 378 urges the needle carrier 376 and (because the introducer needle 394 is attached to the needle carrier 376) upward toward the button assembly 360 (see FIG. 71 ). The upward movement of the needle carrier 376 continues until the spring fingers 380, 382 are captured by the slide component upper tabs 386. At this point, the needle carrier 376 is locked into the end position and the introducer needle 394 is completely inside the housing portion 352. The infusion set 398 is attached to the user, and the cannula 396, which is part of the infusion set, is successfully inserted into the user.

[0103] Thus, the needle carrier 376 is slidably movable from a start position (FIG. 63) to an injection position (FIG. 68) and then to an end position (FIG. 70). The button assembly / rotatable portion of the housing / rotatable button assembly 360 rotates from a locked position to an unlocked position. By exerting a downward force on the rotatable button assembly 360, the rotatable button assembly 360 moves downward, which urges the slide component 374 downward (through the interaction between the ramps 368, 369 and the slide component tabs 370, 372), urging the needle carrier 376, which is attached to the introducer needle 394, downward toward the user's skin. Once the needle carrier 376 reaches the injection position, the spring fingers 380, 382 are pushed inward, and the needle spring 378 urges / urges the needle carrier 376 to move upward toward the rotatable button assembly 360 until it stops at the end position.

[0104] In various embodiments, the infusion set 398 includes an adhesive layer 404. In some embodiments, the adhesive may be covered by a liner, such as the adhesive liner 366. In some embodiments, the user / caregiver removes the adhesive liner before placing the inserter assembly 350 against the skin. In some embodiments, an adhesive liner is not included.

[0105] The various bases, connectors, inserters, and portions thereof may be formed from any material, including, but not limited to, medical-grade plastic materials. The various needles described herein may be formed from any medical-grade material. The cannulas and tubing may be formed from any medical-grade material. In various embodiments, an insertion set includes a base, a connector, tubing, and a luer or other connector configured to connect to a fluid source.

[0106] Although several embodiments have been described, it should be understood that various modifications may be made and, therefore, other embodiments are within the scope of the following claims.

[0107] While the principles of the present invention have been described herein, it should be understood by those skilled in the art that this description is made only by way of example and not as a limitation on the scope of the invention. Other embodiments are contemplated within the scope of the present invention in addition to the exemplary embodiments shown and described herein. Modifications and substitutions by those skilled in the art are deemed to be within the scope of the present invention.

Claims

[Claim 1] The invention as described in the drawings of this application.

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